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Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder (Premalocom2)

Primary Purpose

Prematurity, Extreme Prematurity, Infant Development

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
Sponsored by
Marianne Barbu-Roth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prematurity focused on measuring Prematurity, Crawling, Early intervention, Motor development, Locomotion

Eligibility Criteria

39 Weeks - 42 Weeks (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Term between 24-26 GA or 26-32 GA with suspected brain lesion parental consent family living in intervention area good tolerance on the first crawliskate trial Exclusion Criteria: no bronchodysplasia defined by oxygen dependency after 36 GA no medical disease no limb deformity no karyotype anomaly no visual or auditory impairment

Sites / Locations

  • Cnrs Umr 8002Recruiting
  • Hôpital Robert DebréRecruiting
  • Hôpital Paris Saint-JosephRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Crawli Group

Control Group

Arm Description

Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care

Control group infants benefit from usual care

Outcomes

Primary Outcome Measures

Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.

Secondary Outcome Measures

Amiel-Tison Neurological Assessment
Infant neurological examination at study entry and after the training
Prechtl assessment
General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
Age and Stage questionnaire (ASQ) 3
Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.
2D & 3D analysis of movement
2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.
Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 2, 6, 9, 12 and 24 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.

Full Information

First Posted
August 31, 2023
Last Updated
September 8, 2023
Sponsor
Marianne Barbu-Roth
Collaborators
Ecole Pratique des Hautes Etudes, Université Paris Cité, San Francisco State University, Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT06027645
Brief Title
Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder
Acronym
Premalocom2
Official Title
Effects of Early Crawling Training Via a Mini-Skateboard on the Motor Development of Very Premature Infants at Risk For Neurodevelopmental Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 29, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marianne Barbu-Roth
Collaborators
Ecole Pratique des Hautes Etudes, Université Paris Cité, San Francisco State University, Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Extreme prematurity is constantly increasing according to the World Health Organization. However, methods to train premature infants at risk of disability is sorely lacking. The goal of this project is to overcome this problem. In previous studies, the investigators discovered that promoting the crawling of typical newborns on a mini skateboard, the Crawliskate (a new tool that the investigators designed and patented EP2974624A1), is an excellent way to stimulate infants' motor and locomotor development. This method is a promising way to provide early interventions in infants at heightened risk for developmental delay, such as premature infants. The specific objective of this study is to determine if early training in crawling on this mini skateboard will accelerate motor (particularly locomotor) and/or neuropsychological development in very premature infants identified as high risk for developmental delay. Methodology: The investigators will study and follow two groups of very premature infants born between 24 and 26 weeks of gestational age or born between 26 and 32 with major brain lesions. These infants will be recruited before their hospital discharge at the NICU. After their discharge from the hospital, one group of infants will be trained at home by their parents under the supervision of physiotherapists to crawl on the Crawliskate every day for 2 months (Crawli group), and one group of infants will receive regular medical care (Control group). All infants will be tested for: 1)their crawling proficiency on the Crawliskate at term-equivalent age (just before training for the trained groups) and at 2 and 6 months corrected age (CA, i.e., age determined from the date on which they should have been born), 2) their motor proficiency between 2 and 12 months CA (2D and 3D recording of head control, sitting, crawling, stepping, walking) and 3) their neurodevelopmental, motor and neuropsychological development between 0 and 28 months CA: BSID III edition, ASQ-3, Amiel-Tison's Neurological Assessment, Prechtl Assessment of general movements. One more ASQ-3 questionnaire will be provided at five years. Expected results: The first research hypothesis is that premature infants trained daily to crawl (for two months after discharge from the NICU) will acquire proficient crawling patterns and develop earlier and more effective motor and neuropsychological development than premature infants who receive no training.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Extreme Prematurity, Infant Development, Brain Damage, Motor and Developmental Delay
Keywords
Prematurity, Crawling, Early intervention, Motor development, Locomotion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Crawli Group
Arm Type
Experimental
Arm Description
Participants from the Crawli Group will benefit from the crawling stimulation intervention with a mini-skateboard (i.e. the crawliskate) in addition to usual care
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Control group infants benefit from usual care
Intervention Type
Behavioral
Intervention Name(s)
Crawling stimulation with a mini-skateboard (i.e. the crawliskate)
Intervention Description
Consists of 8 weeks of daily training. Infants benefit from a 10 minutes session everyday at home with either a trained therapist or his/her parents. Parents are trained by the therapist at the begining of the 8 weeks. During each session the infant is prone wrapped on a mini-skateboard (i.e. the crawliskate) and has to produce flexion and extension movements with his four limbs in order to move forward with the assistance of the adult (therapist or parent).
Primary Outcome Measure Information:
Title
Gross motor score from the Bayley Scale of Infant and toddlers Development III ed.
Description
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 12 months corrected age we only evaluate gross and fine motor scores, and we consider the gross motor score obtained at 12 months corrected age as the primary outcome of our study. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
Time Frame
12 months corrected age
Secondary Outcome Measure Information:
Title
Amiel-Tison Neurological Assessment
Description
Infant neurological examination at study entry and after the training
Time Frame
at 39-42 gestational age, 2, 9, 12 months corrected age
Title
Prechtl assessment
Description
General movements assessment by video recording: measures the fluency and variability of spontaneous movement while the infant is lying supine on a mattress
Time Frame
at 39-42 gestational age and 2 months corrected age
Title
Age and Stage questionnaire (ASQ) 3
Description
Parental appreciation of their infant development in personal-social, communication, gross motor, fine motor and problem solving domain The minimal score is 0 and the maximal score is 60. A higher score means more advanced skills.
Time Frame
2, 6, 9, 12, 18, 28 corrected age and 5 years
Title
2D & 3D analysis of movement
Description
2D & 3D analysis of movement (head control, sitting, crawling, stepping, walking) using a motion capture system.
Time Frame
at 39-42 gestational age, 2, 6, 9, 12 months corrected age
Title
Fine and gross motor scores from the Bayley Scale of Infant and toddlers development III ed.
Description
The Bayley Scale of Infant and toddlers Development III ed. (BSID III) assesses several aspect of development: motor, fine motor, communication, personal social, language and problem solving domain. A score can be obtained for each aspect. At 2, 6, 9, 12 and 24 months corrected age we only evaluate fine and gross motor scores. Note that the gross motor score obtained at 12 months corrected age is the primary outcome of our study but the fine motor score obtained at 12 months corrected age is also a secondary outcome. The minimal score is 0 and there is no maximal score (the child is asked to complete several tasks, and the test can continues with questions from an upper age and only stops when a child no longer succeed with the tasks to complete). A higher score means more advanced skills.
Time Frame
2, 6, 9, 12, 24 months corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
39 Weeks
Maximum Age & Unit of Time
42 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Term between 24-26 GA or 26-32 GA with suspected brain lesion parental consent family living in intervention area good tolerance on the first crawliskate trial Exclusion Criteria: no bronchodysplasia defined by oxygen dependency after 36 GA no medical disease no limb deformity no karyotype anomaly no visual or auditory impairment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marianne Barbu-Roth, PhD
Phone
00336 18 61 09 15
Email
barburoth@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie Hinnekens, PT, PhD
Phone
00336 31 75 24 20
Email
elodie.hinnekens@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marianne Barbu-Roth, PhD
Organizational Affiliation
Centre National de la Recherche Scientifique, France
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Valérie Biran, MD, PhD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cnrs Umr 8002
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75006
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marianne Barbu-Roth, PhD
Phone
0033618610915
Email
barburoth@gmail.com
First Name & Middle Initial & Last Name & Degree
Elodie Hinnekens, PT, PhD
Phone
0033631752420
Email
elodie.hinnekens@gmail.com
Facility Name
Hôpital Robert Debré
City
Paris
State/Province
Ile De France
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valérie Biran, MD, PhD
Phone
00336 88 48 48 85
Email
valerie.biran@aphp.fr
Facility Name
Hôpital Paris Saint-Joseph
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Boujenah, MD
Email
lboujenah@ghpsj.fr

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be made available upon reasonable request to corresponding author
IPD Sharing Time Frame
From 2025 to 2030
IPD Sharing Access Criteria
IPD will be made available upon reasonable request to corresponding author

Learn more about this trial

Early Intervention Based on Neonatal Crawling in Very Premature Infants at Risk For Neurodevelopmental Disorder

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